Theranos has confirmed it has withdrawn its request for FDA Emergency Use Authorization for its miniLab Zika virus blood test, following an inspection by the agency.
The company sought agency permission to use for Zika testing its Theranos Sample Processing Unit or miniLab, designed to integrate into a single miniature platform the company’s different testing methods, including hematology, immunology, clinical chemistry, immunochemistry, and nucleic acid amplification.
Theranos publicly unveiled miniLab at the 68th American Association for Clinical Chemistry (AACC) Annual Meeting: “It’s the beginning of the next phase of the company,” CEO Elizabeth Holmes declared.
Theranos is eager to move beyond problems that culminated last month in sanctions imposed on its Newark, CA, laboratory by the Centers for Medicare & Medicaid Services (CMS). CMS’ sanctions included revoking the lab’s CLIA certificate, and banning Holmes from owning, operating, or directing a lab for at least two years. Theranos has said it will appeal the CMS penalties, adding that it has made substantial progress toward correcting the deficiencies identified by the agency.
During an inspection earlier this month, the FDA concluded that Theranos had collected some data supporting the test’s accuracy without implementing a patient-safety protocol approved by an institutional review board, The Wall Street Journal reported.
Theranos has not commented on that account, a spokesman told GEN, though the company has issued a statement by Dave Wurtz, vice president of regulatory, quality and clinical affairs: “We hope that our decision to withdraw the Zika submission voluntarily is further evidence of our commitment to engage positively with the agency. We are confident in the Zika tests and will resubmit it.”
“In my mind, this was a positive interaction with the FDA, and I’m grateful for its collaborative approach,” Wurtz added.
An FDA spokeswoman, Tara Goodin, would not comment on the Theranos application, citing the agency’s policy of not confirming or discussing current and pending product applications. The FDA considers information regarding an application that has yet to receive a decision as proprietary and belonging to the manufacturer/sponsor.
The FDA maintains a database of Establishment Inspection Reports and “Form 483” reports notifying company management of objectionable conditions. No information about Theranos and the miniLab application had been posted at deadline.